Pronunciation: van DET a nib

Brand: Caprelsa

What is the most important information I should know about vandetanib?

You should not use this medicine if you have severe liver disease, a personal or family history of Long QT syndrome, or if you have low blood levels of calcium, potassium, or magnesium.

Call your doctor right away if you have a headache with chest pain and severe dizziness, fainting, and fast or pounding heartbeats.

What is vandetanib?

Vandetanib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Vandetanib is used to treat thyroid cancer.

Vandetanib is available only from a certified pharmacy under a special program called Caprelsa REMS Program. You must be registered in the program and understand the risks of taking this medicine.

Vandetanib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking vandetanib?

You should not use vandetanib if you are allergic to it, or if you have:

  • severe liver disease;
  • a personal or family history of long QT syndrome; or
  • low levels of calcium, magnesium, or potassium in your blood.

To make sure vandetanib is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, or a heart rhythm disorder;
  • overactive thyroid;
  • kidney disease;
  • liver disease;
  • low levels of calcium, magnesium, or potassium in your blood;
  • epilepsy or other seizure disorder;
  • a history of breathing problems;
  • severe diarrhea;
  • skin problems;
  • if you have recently coughed up blood; or
  • if you take other medications.

Do not use vandetanib if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication and for at least 4 months after your treatment ends.

It is not known whether vandetanib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking vandetanib.

How should I take vandetanib?

Vandetanib is usually taken once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take vandetanib with or without food.

Do not crush a vandetanib tablet. Swallow the pill whole.

To make swallowing easier, place the tablet into a glass of water (2 ounces) and stir until the tablet is dispersed in the water. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add 4 ounces more water to the same glass, swirl gently and drink right away.

The dispersed tablet mixture can also be given through a nasogastric (NG) or gastronomy feeding tube. Follow your doctor's instructions.

Do not use a broken pill. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet or capsule.

While using vandetanib, you may need frequent blood tests. Your heart rate may also need to be checked using an electrocardiograph or ECG (sometimes called an EKG) every 2 weeks to 3 months during treatment. Your dose or medication schedule may be changed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using vandetanib. You may need to stop using the medicine for a short time.

Do not stop taking this medication unless your doctor tells you to. If you stop taking vandetanib for longer than 2 weeks for any reason, do not start taking it again without your doctor's advice.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking vandetanib?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking vandetanib.

Avoid exposure to sunlight or tanning beds. Vandetanib can make you sunburn more easily, for up to 4 months after you stop taking the medicine. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of vandetanib?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using vandetanib and call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • confusion, change in mental status, thinking problems, seizure (convulsions), loss of consciousness;
  • new or worsening cough, wheezing, shortness of breath;
  • swelling, rapid weight gain;
  • severe or ongoing diarrhea;
  • dry skin, acne, blisters, itching, peeling, redness, or swelling;
  • easy bruising, unusual bleeding;
  • signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
  • dangerously high blood pressure --severe headache, pounding in your neck or ears, anxiety, irregular heartbeats;
  • thyroid symptoms --extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

You may need to stop taking vandetanib permanently if you have a severe skin reaction.

Common side effects may include:

  • high blood pressure (severe headache, pounding in your neck or ears);
  • diarrhea, stomach cramps;
  • headache;
  • acne, skin rash;
  • nausea, loss of appetite; or
  • cold symptoms such as stuffy nose, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect vandetanib?

Many drugs can interact with vandetanib. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with vandetanib, especially:

  • anagrelide, arsenic trioxide, droperidol, methadone;
  • an antibiotic --azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine, rifampicin;
  • an antidepressant --citalopram, escitalopram;
  • anti-malaria medication --chloroquine, halofantrine;
  • heart medicine --amiodarone, digoxin, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, quinidine, sotalol;
  • medicine to prevent nausea and vomiting --dolasetron, ondansetron, granisetron; or
  • medicine to treat a psychiatric disorder --chlorpromazine, haloperidol, pimozide, thioridazine.

This list is not complete and many other drugs can interact with vandetanib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about vandetanib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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